Syringe assembly having disabling mechanism

ABSTRACT

A syringe assembly having passive disabling structure includes a barrel and a plunger rod assembly. The plunger rod assembly includes a plunger rod and a stopper connected by an indexing locking element. The number of strokes of the syringe plunger before the stopper is locked into the barrel rendering the syringe assembly unusable is determined by the number of detents on the plunger rod and stopper which engage the locking mechanism. Upon completion of the final delivery stroke, any attempt to withdraw the plunger rod from the barrel will cause the locking element to engage the barrel and trap the stopper in the barrel preventing further use of the syringe.

FIELD OF THE INVENTION

The present invention relates to syringe assemblies and particularly tosyringe assemblies having an automatic disabling mechanism.

BACKGROUND

Throughout the world the multiple use of hypodermic syringe productswhich are intended for single-use only, is instrumental in drug abuseand in the transfer of contagious diseases. Intravenous drug users whoroutinely share and re-use syringes are a high-risk group with respectto the AIDS virus. Also, the effects of multiple use are a major concernin some countries where repeated use of syringe products during massimmunization programs may be responsible for the spread of manydiseases. Re-use of single-use hypodermic syringe assemblies is alsoinstrumental in the spread of drug abuse even in the absence ofinfection or disease.

Many attempts have been made to remedy this problem. Most notable areearly contributions which relied on a specific act to destroy thesyringe after use either by using a destructive device or providing asyringe assembly with frangible zones so that the syringe could berendered inoperable by the application of force. Other attempts involvethe inclusion of structure which would allow the destruction ordefeating of the syringe function to a conscious act by the syringeuser. Although many of these devices work quite well, they do requirethe specific intent of the user followed by the actual act to destroy orrender the syringe inoperable. These devices are not effective with auser having the specific intent to re-use the hypodermic syringe.Accordingly, there was a need for a single-use hypodermic syringe whichafter use will become inoperable or incapable of further useautomatically without any additional act on the part of the user. Theautomatic function is much harder to provide because the means forrendering the syringe inoperable must not prevent its filling or useunder normal conditions.

A single-use syringe which automatically disables after injection istaught in U.S. Pat. No. 4,973,310 to Kosinski. This syringe contains alocking element positioned in the syringe barrel between the plunger rodand the inside surface of the barrel. In use, the syringe allows theuser to draw a pre-selected amount of medication into the chamber of thebarrel and deliver this medication, as through injection, into thepatient. Any attempt to withdraw the plunger to use the syringe a secondtime will cause the locking element to embed itself into the insidesurface of the syringe barrel to prevent proximal motion of the plungerrod.

There is still a need for a single-use syringe which will allow apre-selected number of plunger rod strokes before the automaticdisabling mechanism activates. For example, four strokes of the plungermay be required to complete the injection process, such as when thesyringe assembly is used to draw a diluent into the syringe barrel,dispense the diluent into a vial containing the substance to bereconstituted, drawing back the reconstituted medication into thesyringe and then delivering the contents of the syringe into thepatient.

SUMMARY OF THE INVENTION

The present invention is directed to a syringe assembly having a passivedisabling mechanism. The disabling mechanism enables variable dosages bythe syringe assembly and enables a selected number of cycles or strokesby the plunger rod before being disabled. In one preferred embodiment,the disabling mechanism provides two aspirating and two dispensingcycles before being disabled. The assembly enables the aspiration anddispensing of a selected volume of a diluent into a vial to reconstitutea drug, pharmaceutical agent, or other substance and then aspirating thereconstituted substance back into the syringe. A selected volume of thereconstituted substance can be injected or delivered to a patient wherethe volume of the substance that is delivered can be the same ordifferent than the volume of the substance aspirated into the syringebarrel. The syringe is automatically disabled after the injection ordelivery stroke.

The disabling mechanism is actuated by the axial movement of the plungerrod with respect to the syringe barrel and to the stopper, by moving theplunger rod in the aspirating direction. The stopper is coupled to theplunger rod through means or structure that allows limited axialmovement of the stopper with respect to the plunger rod. The disablingmechanism is moved through a series of stages by reversing the directionof the axial movement of the plunger rod with respect to the stopper tomove the mechanism in a step-wise manner to the disabling position. Thedisabling position of the mechanism is attained by the relative movementbetween the plunger rod and the stopper and is not dependent on theposition of the stopper within the syringe barrel or the length of thestroke by the stopper. In this manner, the syringe assembly is able todispense a desired volume of the drug or other substance, and thedisabling mechanism can be actuated after the final dispensing orinjection stroke regardless of the position of the stopper in thesyringe barrel. By actuating the disabling mechanism, the stopper cannotbe retracted to aspirate another dose into the syringe barrel but allowsany substance remaining in the syringe barrel to be dispensed.

The present syringe assembly provides an improvement over prior artdevices by allowing a variable dose of diluent, chosen by the user atthe time of use, to be drawn into the syringe, dispensing the diluentinto a vial containing a substance to be reconstituted, drawing aselected amount of the reconstituted substance back into the syringe andthen delivering the contents of the syringe. The selected amount of thereconstituted substance may be equal or less than the full volumereconstituted at the discretion of the user. The syringe assembly isautomatically disabled after the final injection stroke. After theinjection stroke of the syringe plunger, the disabling mechanism isactivated to prevent axial movement of the stopper toward the proximalend of the syringe barrel thereby preventing the stopper from beingremoved and preventing reuse of the syringe to draw fluid into itschamber.

When the present syringe assembly has two or more detents on the stopperand one or more detents in the plunger rod, the maximum number ofstrokes the syringe assembly will allow can be varied by the initialposition of the locking element with respect to the stopper detents andthe plunger rod detents.

The present syringe assembly provides an improvement over prior artdevices by providing a means or structure wherein the elements whichallow the lost motion between the plunger rod and the stopper arecontained internally within the plunger rod, safe from attempts todeflect the syringe barrel and plunger to defeat the locking mechanism.If these elements were on the outside of the plunger rod, it may bepossible to deflect the barrel to contact the elements and defeat thelocking mechanism.

Another important advantage of the present invention is that in manyembodiments, detents and discontinuities that function to achieve thedesired result are annular, so that rotating the plunger rod withrespect to the barrel will not distort, damage or defeat the lockingelement. A single use syringe will not be effective if it can be easilymanipulated to overcome the locking mechanism for removing thecomponents for re-assembly and reuse.

A further major advantage of the present invention is the singlefrangible zone in the stopper. In many designs there is no single pointwhere a breaking feature may be added effectively and two or morecomponents will have to be orchestrated to break under the same appliedforce to the plunger rod in an attempt to defeat the locking mechanism.In the present invention only one area needs to be weakened and it iscentrally located safe from outside manipulation.

An operable syringe assembly having a passive disabling structureincludes a barrel having a side wall with an inside surface defining achamber for retaining fluid, an open proximal end and a distal endincluding a distal wall having a passageway therethrough in fluidcommunication with the chamber. An elongate plunger rod includes aproximal end and an open distal end having an interior surface defininga cavity therein with at least one detent on the interior surface of theplunger rod. A secondary cavity is included at the proximal end of thecavity in the plunger rod. The secondary cavity has a distal end and aproximal end and includes a contact surface and at least onediscontinuity in the cavity. A stopper includes a sealing element havinga peripheral surface forming a seal with the inside surface of thebarrel, and a post extending proximally from the sealing element havinga proximal end and a distal end. There are at least two post detents onthe post. A secondary post extends proximally axially from the proximalend of the post. The secondary post includes a proximal end and a distalend and at least one discontinuity on its surface. The secondary post ispositioned at least partially in the secondary cavity of the plungerrod. Means or structure for limiting motion is provided to allow thestopper to move freely axially with respect to the plunger rod for alimited distance so that the plunger rod can move while the stopperremains stationary in the barrel and for transferring proximally anddistally directed forces applied to the plunger rod to the stopper. Insome embodiments the distance of this lost motion between the stopperand the plunger rod is determined by the secondary post contacting acontact surface in the secondary cavity of the barrel and thediscontinuity on the secondary post contacting the secondary cavitydiscontinuity in the plunger rod. Any combination of discontinuities inthe secondary cavity and/or on the secondary post that provide for alimited distance of lost motion is within the purview of the presentinvention. A locking element includes a central body portion having anaperture therethrough, at least one cantilevered leg extending distallyoutwardly from the body portion, and at least one finger elementextending inwardly into the aperture. The cantilevered leg includes asharp-free end directed outwardly for engaging the inside surface thebarrel and the inside surface of the plunger rod. The locking element isinitially positioned with the sharp-free end contacting the interiorsurface of the plunger rod proximally of the at least one detent in theplunger rod. The post is positioned in the aperture of the lockingelement wherein the finger element is contacting the proximal most ofthe at least two post detents, so that applying a proximally-directedforce to the plunger rod while holding the barrel causes the plunger rodto move proximally with respect to the stopper until the free end of thecantilevered leg moves distally along the inner surface of the plungerrod cavity to the at least one detent in the cavity and the means orstructure for limiting motion causes the stopper to move with theplunger rod in a proximal direction for a selected distance.Subsequently applying a distally directed force to the plunger rod todischarge fluid from the chamber causes the plunger rod to move in adistal direction along with the locking element due to its engagementwith the at least one detent in the cavity until the means or structurefor limiting motion causes the stopper to move distally along with theplunger rod to discharge fluid from the chamber. Subsequently applying aproximally-directed force to the plunger rod will cause the plunger rodto move proximally with the free end of the cantilevered leg movingrelatively distally along the inside surface of the plunger rod past thedistal end of the plunger rod so that the cantilevered leg engages theinside surface of the barrel to help prevent proximal movement of thestopper for rendering the syringe assembly unusable.

Other embodiments may include a plunger rod with two axially-spaceddetents, and a post with three axially-spaced post detents so that theplunger rod can be moved distally two times before proximal motion ofthe plunger rod causes the locking element to engage the inside surfaceof the barrel.

The two axially-spaced detents of the plunger rod may include twoaxially-spaced steps, each having a blunt surface at its distal endextending inwardly from the interior surface of the plunger rod.

Some or all of the three axially-spaced post detents may include anincline surface extending proximally inwardly and a blunt surface at thedistal end of each of the inclined surfaces extending radially inwardly.

The syringe assembly may include a locking element having twocantilevered legs positioned on opposite sides of the central bodyportion.

The means or structure for limiting free axial motion of the stopperwith respect to the plunger rod may include at least one motion limitingdiscontinuity on the secondary post positioned to engage at least onemotion limiting discontinuity in the secondary cavity. The at least onemotion limiting discontinuity on said secondary post may include anoutwardly directing projection and the at least one motion limitingdiscontinuity in the plunger rod secondary cavity may include aninwardly directed projection.

The syringe assembly may include a radial projection or cam surface onthe stopper positioned to contact and force the cantilevered legoutwardly when excessive proximal force is applied to the plunger rod inan attempt to overcome the locking element's engagement of the insidesurface of the barrel.

The syringe assembly may further include a frangible zone on the stopperwhich allows the plunger rod to disconnect from the stopper sealingelement during application of excessive proximally-directed force to theplunger rod in an attempt to overcome the locking element's engagementof the inside surface of the barrel. The frangible zone may comprise anarea of reduced cross-sectional area which is weaker than the post andthe secondary post in areas outside of the zone. The frangible zone ispositioned within the plunger rod. Only one frangible zone is necessary.

The syringe assembly may have a discontinuity on the inside surface ofthe barrel side wall positioned to engage the sharp-free end of thelocking element when the sharp-free end is in contact with the insidesurface of the barrel.

The syringe assembly may include a distal wall on the barrel having anelongate tip extending distally therefrom having a passageway in fluidcommunication with the passageway with the distal wall of the barrel.The syringe assembly may also further include a needle cannula having adistal end, a proximal end and a lumen therethrough. The proximal end ofthe needle cannula is connected to the distal end of the barrel so thatthe lumen is in fluid communication with the passageway.

Another embodiment of an operable syringe assembly of the presentinvention having passive disabling structure includes a barrelcomprising a side wall having an inside surface defining a chamber forretaining fluid, an open proximal end and a distal end including adistal wall having a passageway therethrough in fluid communication withthe chamber. An elongate hollow plunger rod having a proximal end, anopen distal end and an interior surface defining a cavity is provided. Astopper includes a sealing element with a peripheral surface forming aseal with the inside surface of the barrel and a post projectingproximally from the sealing element. A locking element includes acentral body portion having at least one cantilevered leg extendingdistally outwardly from the body portion. The at least one leg includesa sharp free and directed outwardly for engaging the inside surface ofthe barrel. The locking element is movably engaged with the post andmovably engaged with the plunger rod interior surface. Means orstructure is provided for indexing the locking element distally in theplunger rod during proximal motion of the plunger rod to draw fluid intothe chamber and for indexing the locking element distally on the post ofthe stopper during distally directed motion of the plunger rod fordelivering fluid from the chamber through the passageway. Structure ormeans is also provided for limiting axial free movement of the stopperwith respect to the plunger rod to allow the indexing of the lockingelement and for applying proximally and distally directed forces to thestopper through the plunger rod.

The locking element may be made of sheet metal such as stainless steeland the stopper may be integrally formed of thermoplastic material.

Another embodiment of an operable syringe assembly of the presentinvention includes means or structure for controlling the free axialmotion of the stopper with respect to the plunger rod to help preventaccidental or unintended movement of the plunger rod with respect to thestopper to avoid cycling the passive disabling elements of the syringeassembly while not using it for its intended purpose. Structure or meansfor controlling free axial motion of the stopper with respect to theplunger may include the inwardly directed projection on the plunger rodhaving a free end frictionally contacting the outside surface of thesecondary post increasing the force required to move the stopper withrespect to the plunger rod.

The structure or means for controlling the free axial motion of thestopper with respect to the plunger rod may also include a proximalrecess in the outside surface of the secondary post adjacent to theoutwardly directed projection on the secondary post and a distal recessin the outside surface of the secondary post spaced from the proximalrecess wherein the distance between the proximal distal recessescorresponds to the free axial motion of the stopper with respect to theplunger rod, with the free end of the inwardly directed projection beingin the distal recess when the seal of the stopper is closest to theplunger rod and in the proximal recess when the seal of the stopper isfarthest from the plunger rod. The force applied to the plunger rod tomove the free end of the inwardly directed projection out of either ofthe recesses is greater than the force required to move the free endalong the outside surface of the secondary post between the recesses,thereby holding the stopper in its distal most and proximal mostpositions until the application of the greater force. It is preferredthat the recesses in the secondary post are configured so that when thestopper and the plunger rod are in their extreme positions with respectto each other, the free end of the inwardly directed projectionpreferably exerts substantially zero force on the surface of therecesses and desirably no more than 25% of the force the inwardlydirected projection exerts on the outside surface.

The structure or means for controlling may include a distal recess inthe outside surface of the secondary post near the distal end of thesecondary post, wherein the free end of said inwardly directedprojection is in the distal recess when the seal of said stopper isclosest to the plunger rod so that the force applied to said plunger rodto move the free end of the inwardly directed projection out of thedistal recess is greater than the force required to move the free endalong the outside surface of the secondary post thereby holding saidstopper in its position with respect to the plunger rod until theapplication of said greater force.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of the syringe assembly of the presentinvention.

FIG. 2 is a side-elevational end view of the proximal end of the syringeassembly of FIG. 1.

FIG. 3 is a cross-sectional view of the syringe assembly of FIG. 1 takenalong line 3-3.

FIG. 4 is a perspective view of the plunger rod of the syringe assemblyviewed from its proximal end.

FIG. 5 is a perspective cross-sectional view of the plunger rod viewedfrom its distal end.

FIG. 6 is a perspective view of the locking element of the syringeassembly viewed from its distal end.

FIG. 7 is a perspective view of the locking element viewed from itsproximal end.

FIG. 8 is a perspective view of the stopper of the syringe assemblyviewed from its proximal end.

FIG. 9 is an exploded perspective view of the syringe assembly.

FIG. 10 is an enlarged partial cross-sectional view of the syringeassembly of FIG. 3 showing the syringe assembly before use.

FIG. 11 is an enlarged partial cross-sectional view of the syringeassembly of FIG. 3 showing the syringe assembly after the firstaspiration stroke.

FIG. 12 is an enlarged partial cross-sectional view of the syringeassembly of FIG. 3 showing the syringe assembly during a firstdispensing stroke.

FIG. 13 is an enlarged partial cross-sectional view of the syringeassembly of FIG. 3 showing the syringe assembly at the start of a secondaspiration stroke.

FIG. 14 is an enlarged partial cross-sectional view of the syringeassembly of FIG. 3 showing the syringe assembly after a secondaspiration stroke.

FIG. 15 is an enlarged partial cross-sectional view of the syringeassembly of FIG. 3 showing the syringe assembly during a seconddispensing stroke.

FIG. 16 is an enlarged partial cross-sectional view of the syringeassembly of FIG. 3 showing the syringe assembly after a seconddispensing stroke.

FIG. 17 is an enlarged partial cross-sectional view of the syringeassembly of FIG. 3 showing a position of the internal componentsincluding additional structure for preventing reuse in the event of anattempt to withdraw the plunger rod after the second dispensing stroke.

FIG. 18 is an enlarged partial cross-sectional view of the syringeassembly of FIG. 16 showing the further interaction of the additionalstructure to prevent reuse.

FIG. 19 is an enlarged partial cross-sectional view similar to thesyringe assembly of FIG. 18 showing a discontinuity in the syringebarrel for engaging the locking element.

FIG. 20 is an enlarged partial cross-sectional view of the syringeassembly of FIG. 19 showing the breaking of the stopper at a frangiblezone.

FIG. 21 is an enlarged partial cross-sectional view of an alternativeembodiment of the syringe assembly of the present invention.

FIG. 22 is a side-elevational view of an alternative stopper of thesyringe assembly of the present invention.

FIG. 23 is an enlarged partial cross-sectional view of a syringeassembly using the stopper of FIG. 22 showing the syringe assemblybefore injection.

FIG. 24 is an enlarged partial cross-sectional view showing theinteraction between the stopper and plunger rod of the syringe assemblyof FIG. 23.

FIG. 25 is an enlarged partial cross-sectional view of the syringeassembly of FIG. 23 showing the syringe assembly after the secondaspiration stroke.

FIG. 26 is an enlarged partial cross-sectional view showing theinteraction between the stopper and plunger rod of the syringe assemblyof FIG. 25.

DETAILED DESCRIPTION

Referring to FIGS. 1-18, a syringe assembly 20 having passive disablingfeatures includes a barrel 21 and a plunger assembly 22. Barrel 21includes a cylindrical side wall 23 having an inside surface 24 defininga chamber 25 for retaining fluid. The barrel further includes an openproximal end 27 and a distal end 28 including a distal wall 29 having apassageway 32 therethrough in fluid communication with the chamber. Inthis embodiment, the distal wall of the barrel includes an elongate tip31 extending distally therefrom and having a passageway therethrough influid communication with the passageway in the distal wall. In thisembodiment, barrel 21 also includes a needle cannula 37 having aproximal end 38, a distal end 39 and a lumen 40 therethrough. Theproximal end of the needle cannula is attached to elongate tip 31 sothat the lumen of the needle cannula is in fluid communication withpassageway 32 in the barrel. A needle hub may also be attached to theproximal end of the needle cannula. In this configuration the needle hubengages the elongate tip to establish fluid communication between thelumen and the passageway in the barrel.

Plunger assembly 22 includes an elongate plunger rod 43, a stopper 81and a locking element 71. Plunger rod 43 includes a proximal end 44, anopen distal end 45 and interior surface 46 defining a cavity 47 therein.The interior surface of the plunger rod preferably includes at least onedetent. In this embodiment the at least one detent on the interiorsurface of the plunger rod includes two annular axially spaced detents49 on the interior surface of the cavity. Each detent comprises a step50 having a blunt surface 51 at its distal end. As will be explained inmore detail hereinafter, the present invention can function withoutdetents on the interior surface of the plunger rod. The plunger rod alsoincludes a secondary cavity 52 at a proximal end of cavity 47. Thesecondary cavity preferably includes a distal end 53 having a distalcontact surface 61, a proximal end 54 having a proximal contact surface55, and at least one discontinuity therein. In this embodiment thediscontinuity comprises one or more inwardly directed projections 56.The secondary cavity is preferably smaller than cavity 47. The primarypurpose of the secondary cavity is to interact with the stopper so thatthe stopper is free to move axially with respect to the plunger rod fora limited distance. As will be seen hereinafter, this lost motion whichallows the plunger rod to move independently of the stopper allows thelocking element to index through a sequence of positions which end inthe locking of the stopper in the barrel to prevent further use.

Stopper 81 includes a preferably circularly-shaped sealing element 82having a peripheral surface 83 forming a seal with the inside surface ofthe barrel. A post 85 extends proximally from the sealing element andhas a proximal end 87, a distal end 88 and preferably at least twodetents on its surface. In this embodiment, the at least two postdetents includes three axially-spaced post detents 89. Each post detentpreferably but not necessarily, includes an inclined surface 91 and ablunt surface 92 at the distal end of each inclined surface. As will beexplained in more detail hereinafter it is within the purview of thepresent invention to include an embodiment having a post withoutdetents. A secondary post 93 extends proximally axially from theproximal end of post 85. The secondary post includes a proximal end 94,a distal end 95 and at least one discontinuity on its surface. In thisembodiment discontinuity 96 is a radial projection having adistally-facing surface 97 thereon. The secondary post is positioned atleast partially in the secondary cavity of the plunger rod. As mentionedhereinabove, the plunger rod is free to move axially with respect to thestopper for a limited distance which, in this embodiment, is controlledin one direction by the proximal end of the secondary post contactingproximal contact surface 55 in the secondary cavity and/or the proximalmost detent 89 and distal contact surface 61 of the secondary cavity,and in the other direction by the secondary post discontinuitycontacting the secondary cavity discontinuity in the plunger rod.

Locking element 71 includes a central body portion 72 having an aperture73 therethrough. Preferably, at least one cantilevered leg extendsdistally outwardly from the body portion. In this embodiment, there aretwo cantilevered legs 74 extending distally outwardly from oppositesides of body portion 72. A plurality of cantilevered legs or otherspring and/or resilient structures for engaging the interim surface ofthe plunger rod and the inside surface of the barrel are within thepurview of the present invention. At least one finger element 75 extendsinwardly into said aperture. In this embodiment the finger elementextends proximally inwardly from the aperture. Each of the cantileveredlegs preferably includes a sharp-free end 76 directed outwardly fromengaging the inside surface of the barrel. The sharp-free end of thecantilevered leg can be formed in any configuration capable of engagingthe inside surface of the barrel, such as a sharp edge or one or morepointed teeth and the like. The locking element may be made of a varietyof materials, or combinations of materials, however, it is preferred tohave a sharp-free end made of metal, and it is also preferred that theentire locking element be integrally formed from sheet metal such asstainless steel.

In this embodiment, plunger assembly 22 may be assembled by insertinglocking element 71 into the distal end of plunger rod 43. The post ofstopper 81 is then inserted into the distal end of the plunger rodthrough aperture 73 of locking element 71 so that cantilevered legs 74extend towards circularly-shaped sealing element 82 of the stopper asillustrated in FIG. 9. The plunger assembly is then inserted into barrel21 through open proximal end 27 to the initial position illustrated inFIGS. 3 and 10. Also, the syringe assembly may be assembled by insertinglocking element 71 into the distal end of the plunger rod and insertingstopper 81 into the open proximal end of barrel 21, and then insertingthe locking element/plunger rod into the proximal end of the syringebarrel.

In the initial position of the syringe assembly, locking element 71 ispositioned with its sharp-free end 76 contacting the interior surface ofthe plunger rod proximally of axially-spaced steps 50. Post 85 onstopper 81 is positioned in aperture 73 of locking element 71 so thatfinger element 75 contacts the post proximally of two of the threeaxially-spaced post detents 89. The proximal end of the secondary post93 is near or contacting contact surface 55 in proximal end 52 of thesecondary cavity in the plunger rod, and the inclined surface of themost proximal post detent 89 is near or contacting contact surface 61 atthe distal end of the secondary cavity. Contact between the proximal endof the secondary post and contact surface 55 in the secondary cavityand/or contact between the proximal most post detent, and contactsurface 61 defines the proximal most motion of the stopper with respectto the plunger rod. Both contacts are preferred for stronger resistanceto excessive distally directed force on the plunger rod. Stopper 81further includes stabilizing member 84 positioned proximally withrespect to sealing element 82 and having an outer dimensioncomplementing the outer dimension of the sealing element as illustratedin FIG. 10. Stabilizing member 84 has an outer dimension which ispreferably less than the sealing element to assist in stabilizing thestopper to maintain the seal between the peripheral surface of thesealing element and the side surface of the barrel, and to maintain thestopper and post alignment substantially parallel to the axis of thesyringe barrel.

As will be shown, the operation of the plunger assembly of thisembodiment includes a first aspiration stroke followed by a firstdispensing or injection stroke, a second aspirating stroke and a finaldispensing or injection stroke after which the syringe will becomedisabled if another aspiration stroke is attempted. The disablingelements prevent or inhibit movement of the stopper in a proximalaspirating direction thereby limiting the function of the syringeassembly to a single use. The number of strokes in this embodiment iscontrolled by the number of axially-spaced detents in the plunger rodand the number of axially-spaced post detents on the stopper. However,the actual strokes the syringe may make will be determined by theposition of the locking element with respect to the detents in theplunger rod and the detents on the stopper at the time of first use. Forexample, a syringe with two detents in the plunger rod and three stopperpost detents on the stopper can be supplied to the user as a syringecapable of two strokes or four strokes. This is an important feature ofthe invention since a single syringe assembly can be provided withdifferent stroke limitations before disabling.

Referring to FIG. 11, the syringe assembly may now be used to drawliquid, such as sterile water diluent into the chamber of the barrel byapplying a proximally directed force F to a thumb press 57 on theproximal end of the plunger rod while holding the syringe barrel. Thiscauses the plunger rod to move proximally with respect to the stopperuntil distally-facing surface 97 on discontinuity 96 of the secondarypost contacts inwardly-directed projections 56 on the plunger rod. Atthe same time, the free ends of cantilevered legs 74 move distally alongan interior surface 46 of the plunger rod and snap past blunt surface 51of the proximal-most axially-spaced steps 50. The stopper can now bemoved proximally, through action of the plunger rod, until the desiredvolume is in the chamber, as determined by the user. It is an importantfeature of this invention that the user determines the volume, ratherthan the structure of the disabling mechanism dictating the volume as insome prior art devices.

Liquid diluent 33 in the chamber may now be dispensed into a vial of drymedication such as lyophilized medication, for reconstitution. Asillustrated in FIG. 12, the first dispensing stroke is accomplished byapplying force F to the plunger rod, in a distal direction, whileholding the barrel. A barrel flange 30 is provided on the proximal endof the barrel to help control motion of the barrel during use of thesyringe assembly. As the plunger rod moves distally, locking element 71moves with the plunger rod dragging the locking element with it so thatfinger element 75 on the locking element slides from the proximal-mostto the next proximal-most detent by riding up inclined surface 91 andfalling into second of three post detents 89. When the plunger rodcontacts the stopper by action of the proximal end of the secondary postand contact surface 55 in the plunger rod and/or the proximal most postdetent and contact surface 61, the stopper will begin moving in a distaldirection along with the plunger rod to dispense liquid diluent from thechamber into, for example, a vial of lyophilized medication.

When the diluent and the lyophilized medication are mixed, the syringeassembly of the present invention may now be used to withdraw thereconstituted, ready-to-inject medication into the chamber of thesyringe barrel, as best illustrated in FIGS. 13 and 14. By applying aproximally-directed force F to the plunger rod while holding the syringebarrel, the plunger rod will move in a proximal direction while lockingelement 71 will remain relatively stationary due to its connection tothe post detent on the stopper. Proximal motion of the plunger rodcauses the locking element to move relatively distally along the insidesurface of the plunger rod so that the sharp-free ends 76 of thecantilevered legs move from the proximal-most axially-spaced step 50 inthe plunger rod to the second more-distal axially-spaced step 50.Proximal motion of the plunger rod also causes distally-facing surface97 on discontinuity 96 of the secondary post to contactinwardly-directed projections 56 in the secondary cavity so that thestopper now moves proximally with the plunger rod drawing reconstitutedmedication 34 into chamber 25 of the syringe barrel to an amountdetermined by the user. The amount of medication drawn into the chamber,and therefore the maximum amount of medication that can be delivered, isdetermined by the user at the time of use and not by the placement ofthe components at the time of manufacture.

The syringe assembly of the present invention is now ready for a secondand final dispensing or injection stroke which is best illustrated inFIGS. 15 and 16. Medication 34 is delivered to the patient by applying adistally-directed force F to the plunger rod causing the plunger rod tomove in a distal direction with respect to the barrel. As the plungerrod advances in a distal direction engagement of sharp-free ends 76 ofthe locking element with the most distal blunt surface 50 ofaxially-spaced steps 50 moves the locking element distally so thatfinger element 75 of the locking element rides over the distal-mostinclined surface 91 of the post detents distally to the most distal postdetent 89. When the distally-moving plunger rod contacts the stopper,both the stopper and plunger rod move toward the distal end of thebarrel to dispense the contents of the chamber through the passageway.

The syringe assembly has now been used and is ready to be discarded. Anyattempt to move the plunger rod in a proximal direction with respect tothe barrel to refill the syringe assembly for further use will cause thelocking element to disable the syringe. Specifically, as bestillustrated in FIGS. 17 and 18, applying force F to the plunger rod in aproximal direction will allow the plunger rod to move a short distanceuntil the sharp-free ends 76 of the locking element snap past the distalend of the plunger rod and engage inside surface 24 of barrel 21. Inaddition, a radial projection in the form of cam surface 58 on thestopper is positioned to force sharp-free ends 76 of the locking elementfurther into the syringe barrel wall as more proximally-directed forceis used in an attempt to improperly reuse the syringe. The cam surfacemay be annular or there may be one or more individual cam surfacespositioned to contact the locking element cantilevered legs. Cam surface58 also includes a stop 59 to limit the distance the stopper moves in aproximal direction which helps prevent the reuse of the syringe. It isdesirable to limit the proximal motion of the stopper to a distance thatwill only allow the syringe to take in a volume of less than 10% of themedication dose. Accordingly, increased force to pull the plunger rodout of the syringe barrel results in increased force of engagement ofthe sharp-free ends of the locking element into the barrel.

It is also within the purview of the present invention to provide adiscontinuity, such as a recess or projection, on the interior surfaceof the barrel, as illustrated in FIG. 19 to further improve theengagement of the sharp-free end of the locking element with theinterior surface of the barrel. In FIG. 19, syringe barrel 21 includes abarrel discontinuity in the form of an inwardly-directed projection 35on inside surface 24 of the barrel. In this embodiment, projection 35 isan annular ring projecting into the barrel and extending 360° around theinside surface. The discontinuity may be in the form of an annularprojection, an annular recess or one or more projections or recessesshaped to engage sharp-free ends 76 of locking element 71 to furtherincrease the grip of the locking element on the inside surface of thebarrel.

The syringe assembly of the present invention also includes a frangiblezone on stopper 81 positioned distally from discontinuity 96 onsecondary post 93 for allowing the plunger rod to disconnect from thestopper sealing element during the application of excessive,proximally-directed force to the plunger rod in an attempt to overcomethe locking element's engagement of the inside surface of the barrel. Asillustrated in FIGS. 19 and 20, the frangible zone in this embodimentpreferably comprises a zone of reduced cross-sectional area 98 which isweaker in tension than the post 85 and secondary post 93 in areasoutside of the zone. It should be noted that the frangible zone can beachieved in many ways such as forming portions of the stopper separatelyand assembling them using adhesive or mechanical connector in the areaof the frangible zone, altering the area of the zone to be weaker thansurrounding material, forming the stopper of different materials usingthe weakest material to form the zone and the like. The zone of reducedcross-sectional area illustrated herein is merely representative ofthese many possibilities all of which are in the purview of the presentinvention. The frangible zone is an important feature of the presentinvention since the weakest area of the syringe assembly can be locatedin one position and carefully controlled for the force of breaking ordisconnecting, without needing to compromise other elements of thesyringe assembly by having to create multiple frangible zones. Thefrangible zone is also preferably located within the plunger rod whereit is difficult to access from outside of the syringe barrel for thepurpose of defeating the single-use structure of the syringe assembly.

Referring to FIG. 21, an alternative embodiment of the syringe assemblyof the present invention is illustrated. This embodiment functionssimilarly to the embodiment of FIGS. 1-18 with the exception that thereare no detents on the stopper post or in the plunger rod cavity. Asdescribed above, embodiments of FIGS. 1-18 include a barrel having arelatively smooth inside surface to which the sharp-free ends of thecantilevered legs of the locking element engage. In the embodimentsshown in FIGS. 19 and 20 the barrel includes an inwardly-directedprojection. The purpose of this projection is to improve the grip of thefree ends of the cantilevered legs on the inside surface of the barrelto more strongly resist the application of a proximally-directed forceon the plunger to defeat the locking mechanism after the syringe hasbeen used. If the sharp-free ends of the cantilevered legs are sharpenough and angled properly they should be able to resist such forcewithout addition of an inwardly-directed projection on the insidesurface of the barrel. Likewise, the detents on the stopper post and theinterior surface of the plunger rod in the embodiment of FIGS. 1-18, areprovided to assure that locking element will index properly with eachstroke of the plunger with respect to the barrel placing the lockingelement in position to disable the syringe at the completion of the lastdelivery stroke. Detents also allow more latitude in the design of theplunger rod, stopper and locking element such as being able to use abroader range of materials, and to use looser, more cost-effectivetolerances. However, the invention will function without detents on thestopper post and in the plunger rod if an adequately sharp and resilientelement is used with compliant materials. Specifically, as shown in FIG.21, syringe assembly 120 includes a barrel 121 having a cylindrical sidewall 123 and an inside surface 124 defining a chamber 125 for retainingfluid. An elongate plunger rod 143 includes an open distal end 145having an interior surface 146 defining a cavity 147 therein. A stopper181 includes a sealing element 182 having a peripheral surface forming aseal with the inside surface of the barrel. A post 185 extendsproximally from the sealing element having a proximal end 187 and adistal end 188. Locking element 171 includes a central body portion 172having an aperture therethrough. Cantilevered legs 174 benddistally-outwardly from opposite sides of body portion 172. At least onefinger element 175 bends proximally-inwardly from the aperture. Each ofthe cantilevered legs has a sharp free end 176 directed outwardly forengaging inside surface 124 of the barrel and interior surface 146 ofthe plunger rod. The sharp free end of each cantilevered leg isconfigured to move relatively freely in a distal direction and to resistproximally-directed motion by engaging the surface which is contacts.Likewise, finger element 175 is configured to move distally along thepost of the stopper but to resist proximal motion along the post byengaging the stopper post. In all other aspects this embodimentfunctions similarly to the embodiment of FIGS. 1-18.

FIGS. 22-26 illustrate another alternative embodiment of the syringeassembly of the present invention. This embodiment functions similarlyto the embodiment of FIGS. 1-18 except that the stopper includesadditional features on the secondary post to control the free axialmotion of the stopper with respect to the plunger rod. Stopper 281includes a preferably circular-shaped sealing element 282 having aperipheral surface 283 forming a seal with the inside surface of thebarrel, a post 285 extends proximally from the sealing element and has aproximal end 287, a distal end 288 and preferably at least two detentson its surface. In this embodiment the at least two post detents includethree axially-spaced detents 289. Each post detent preferably, but notnecessarily, includes an incline surface 291 and a blunt surface 292 atthe distal end of each inclined surface. A secondary post 293 extendsproximally axially from the proximal end of post 285. The secondary postincludes a proximal end 294, a distal end 295 and at least onediscontinuity on its surface. In this embodiment, discontinuity 296 is aradial projection having a distally-facing surface 297 thereon. Outsidesurface 277 of the secondary post includes a proximal recess 279adjacent to distally facing surface 297 and a distal recess 280 spacedfrom the proximal recess. The distance between the proximal recess andthe distal recess corresponds to the free axial motion of the stopperwith respect to the plunger rod. Free end 62 of inwardly directedprojection 56 on plunger rod 43 is in distal recess 280 when seal 283 ofthe stopper is closest to the plunger rod and proximal recess 279 whenthe seal of the stopper is furthest from the plunger rod. The force thatmust be applied to the plunger rod to move free end 62 of inwardlydirected projection 56 out of either of the recesses is greater than theforce required to move the free end along outside surface 277 of thesecondary post between the recesses, thereby holding the stopper in itsdistal most and proximal most positions until the application of thegreater force. It is preferred that the recesses in the secondary postare configured so that when the stopper and the plunger rod are atextreme positions with respect to each other and the free end of theinwardly directed projection is in either of the recesses that theinwardly directed projection be in a relatively stress-free condition.In these positions, the inwardly directed projection exerts little or noforce on the surface of the recesses. This helps avoid the possibilityof any creep in the thermoplastic components between time of manufactureand time of use and, accordingly, helps insure consistent performancefrom syringe to syringe.

It is an important advantage of the present embodiment that the plungercannot inadvertently or through incidental minor forces applied beforeuse, be cycled back and forth with respect to the stopper advancing thelocking element without drawing fluid into or out of the chamber. Thisconfiguration does not preclude the intentional cycling of the plungerrod with respect to the stopper before use to reduce the number ofcycles the syringe can have before the locking element prevents furthercycling or use.

Even without the proximal and distal recesses, the frictional forcebetween the free end of the inwardly directed projection and the outsidesurface of the secondary post will help prevent inadvertent orunintended cycling of the plunger rod with respect to the barrel. Theconfiguration of the transitional area between the proximal and/ordistal recesses and the outside surface of the secondary post can beconfigured, such as by using the curvilinear cam surface, to help keepthe transitional forces in a range that is lower than the force requiredto move the stopper along the inside of the barrel. Also, the inwardlydirected projection can be configured in many ways to cooperate with theproximal and distal recesses and the outside surface of the secondarypost, and the proximally inwardly directed projection and the relativelystraight geometric transitions between the recesses and the surfaces ofthe secondary post as shown herein are merely representative of thethese many possibilities, all of which are in the purview of the presentinvention.

While various embodiments have been chosen to illustrate the invention,it will be appreciated that changes and modifications can be madewithout departing from the scope of the invention.

1. An operable syringe assembly having passive disabling structurecomprising: a barrel including a side wall having an inside surfacedefining a chamber for retaining fluid, an open proximal end and adistal end including a distal wall having a passageway therethrough influid communication with said chamber; an elongate plunger rod includinga proximal end and an open distal end having an interior surfacedefining a cavity therein, at least one detent on said interior surfaceat said distal end of said plunger rod, a secondary cavity at a proximalend of said cavity, said secondary cavity having a distal end and aproximal end, said secondary cavity having a contact surface and atleast one discontinuity in said secondary cavity; a stopper including asealing element having a peripheral surface forming a seal with saidinside surface of said barrel, a post extending proximally from saidsealing element having a proximal end and a distal end, at least twopost detents on said post, a secondary post extending axially from saidproximal end of said post, having a proximal end, a distal end, anoutside surface and at least one discontinuity on said outside surface,said secondary post being positioned at least partially in saidsecondary cavity; means for limiting free axial motion of said stopperwith respect to said plunger rod for a limited distance and for applyingproximally and distally directed forces to said stopper through saidplunger rod; means for controlling free axial motion of said stopperwith respect to said plunger rod; a locking element including a centralbody portion having an aperture therethrough, at least one cantileveredleg extending distally outwardly from said body portion, and at leastone finger element extending proximally inwardly into said aperture,said at least one leg having a sharp free end directed outwardly forengaging said inside surface of said barrel; said locking element beingpositioned with said sharp-free end contacting said interior surface ofsaid plunger rod proximally of said at least one detent in said plungerrod, said post being positioned in said aperture of said locking elementwherein said at least one finger element is contacting the proximal mostof said at least two post detents, so that applying a proximallydirected force to said plunger rod while holding said barrel causes saidplunger rod to move proximally with respect to said stopper until saidfree end of said cantilevered leg moves distally along said innersurface of said plunger rod cavity to said at least one detent in saidcavity and said means for limiting motion causes said stopper to movealong with said plunger in a proximal direction for a selected distance,and subsequently applying a distally directed force to said plunger rodto discharge fluid from said chamber through said passageway causes saidplunger rod to move in a distal direction along with said lockingelement due to its engagement with said at least two post detents untilsaid means for limiting motion causes said stopper to move distally withsaid plunger rod to discharge fluid from said chamber, after whichapplying proximally directed force to said plunger rod will cause saidplunger rod to move proximally with said free end of said cantileveredleg moving distally along said interior surface of said cavity past saiddistal end of said plunger rod so that said at least one cantileveredleg engages said inside surface of said barrel to help prevent proximalmovement of said stopper to render said syringe assembly unusable. 2.The syringe assembly of claim 1 wherein said means for limiting saidfree axial motion of said stopper with respect to said plunger rodincludes at least one motion limiting discontinuity on said secondarypost positioned to engage at least one motion limiting discontinuity insaid secondary cavity.
 3. The syringe assembly of claim 2 wherein saidat least one motion limiting discontinuity on said secondary postcomprises an outwardly directed projection and said at least one motionlimiting discontinuity in said secondary cavity comprises an inwardlydirected projection having a free end.
 4. The syringe assembly of claim3 wherein said means for controlling free axial motion of said stopperwith respect to said plunger rod includes said free end of said inwardlydirected projection frictionally contacting said outside surface of saidsecondary post increasing the force required to move said stopper withrespect to said plunger rod.
 5. The syringe assembly of claim 4 whereinsaid means for controlling further includes a proximal recess in saidoutside surface of said secondary post adjacent to said outwardlydirected projection on said secondary post and a distal recess in saidoutside surface of said secondary post spaced from said proximal recess,the distance between said proximal and said distal recesses correspondsto said free axial motion of said stopper with respect to said plungerrod, with said free end of said inwardly directed projection being insaid distal recess, when said seal of said stopper is closest to saidplunger rod and in said proximal recess when said seal of said stopperis furthest from said plunger rod, wherein the force applied to saidplunger rod to move said free and said inwardly directed projection outof either of said recess is greater than the force required to move saidfree end along said outside surface of said secondary post between saidrecesses, thereby holding said stopper in its distal most and proximalmost positions until the application of said greater force.
 6. Thesyringe assembly of claim 5 wherein said recesses in said secondary postare configured so that when said stopper and said plunger rod are intheir extreme positions with respect to each other, said free end ofsaid inwardly directed projection exerts substantially zero force on thesurface of said recesses.
 7. The syringe assembly of claim 5 whereinsaid recesses in said secondary post are configured so that when saidstopper and said plunger rod are in their extreme positions with respectto each other, said free end of said inwardly directed projection exertsa force on the surface of said recesses which is less than 25% of theforce said free end exerts on said outside surface of said secondarypost.
 8. The syringe assembly of claim 4 wherein said means forcontrolling further includes a distal recess in said outside surface ofsaid secondary post near said distal end of said secondary post, whereinsaid free end of said inwardly directed projection is in said distalrecess, when said seal of said stopper is closest to said plunger rod,wherein the force applied to said plunger rod to move said free and saidinwardly directed projection out of said distal recess is greater thanthe force required to move said free end along said outside surface ofsaid secondary post, thereby holding said stopper in its proximal mostposition with respect to said plunger rod until the application of saidgreater force.
 9. The syringe assembly of claim 8 wherein said recess insaid secondary post is configured so that when said stopper is in itsproximal most position with respect to said plunger rod, said free endof said inwardly directed projection exerts substantially zero force onthe surface of said recess.
 10. The syringe assembly of claim 8 whereinsaid recess in said secondary post is configured so that when saidstopper is in its proximal most position with respect to said plungerrod, said free end of said inwardly directed projection exerts a forceon the surface of said recess which is less than 25% of the force saidfree and exerts on said outside surface of said secondary post.
 11. Thesyringe assembly of claim 1 wherein said at least one detent in saidplunger rod includes two axially spaced detents and said at least twodetents on said post includes three axially spaced post detents so thatsaid plunger rod can be moved distally two times before proximal motionof said plunger rod causes said locking element to engage said insidesurface of said barrel.
 12. The syringe assembly of claim 11 said atleast one cantilevered leg of said locking element includes twocantilevered legs positioned on opposite sides of said central bodyportion.
 13. The syringe assembly of claim 12 further including tworadial projections on said stopper positioned to engage and force saidtwo cantilevered legs outwardly when excessive proximally directed forceis applied to said plunger rod in an attempt to overcome said lockingelement's engagement of said inside surface of said barrel.
 14. Thesyringe assembly of claim 2 wherein said two axially spaced detents insaid plunger rod include two axially spaced steps each having a bluntsurface at its distal end extending inwardly from said interior surface.15. The syringe assembly of claim 11 wherein said three axially spacedpost detents each include a blunt distally facing surface at a extendingradially outwardly.